FDA: Food & Drug (& App?) Administration

We've been considering FDA oversight of medical apps for a while, over at Medgadget.com. Now, the public comment period has concluded on the FDA's draft of how this oversight might look. The story:

The FDA will scrutinize medical apps that act as an accessory to a medical device and those that transform the mobile device into a medical device. A draft guidance issued by the FDA includes an extensive list of applications that will have to undergo review. Examples of apps that fall under the regulatory oversight are:

* Applications that allow the user to view medical images, such as digital mammography or digital images of potentially cancerous lesions on a mobile platform, and those that perform a health analysis or provide a diagnosis by trained health care professionals.

* Applications that connect to a home use diagnostic medical device to collect historical data, or to receive, transmit, store, analyze, and display measurements from connected devices.

Great, right? The apps that do heavy lifting of patient information and connect to real medical devices get regulated, but the fun and educational apps I am working on remain free and open. Still, Harvey Castro, my favorite EM-doc-and-app-developer, was worried:

“Overall, I believe safety is the most important item when it comes to providing patient care,” said Harvey Castro, MD, an app developer (www.deeppocketseries.com) and emergency physician. “Unfortunately, I believe this will hurt small businesses and entrepreneurs by making it cost-prohibitive to enter the market.”

“Applications will be dominated by a few companies capable of paying the high fees to get FDA approval. I will be saddened to see these changes in the future.”

For their part, the FDA said it's nothing to worry about:

...the FDA said the regulatory requirements will not impede the advancement of medical apps. “We are eager to support the continued development of mobile medical apps without the burdensome regulations that would stifle innovation,” the spokesperson said.

I've perused the FDA's draft and still have a lot of questions. What if I install an app from a non-American app store -- could I still use it on American patients? What are the penalties for apps that should have been submitted for FDA review, but weren't? Will there be a grandfathering status, like with pre-1930's drugs? Will educational app makers have to submit a form asking for FDA exemptions?

The biggest question: will the FDA heed the recent IOM recommendation that another (non-FDA) government agency take up the regulation of EHR vendors? What if Congress fails to create such a body (I have a hard time imagining, in this political environment, how funding for creating a new regulatory agency would transpire). What if the FDA is the only agency that can expand its mandate? Wouldn't it act? Why should FDA expand to medical apps but not EHR?

The FDA has a proud and progressive tradition; the laws underlying its authority were passed in response to public outcry regarding food and vaccine preparation, and misleading labeling. There were big problems, improved by the FDA. Even now, critics argue the FDA doesn't go far enough -- approving medical devices later found to be flawed, and recalled.

So I don't understand this push into an area where they have no clear mandate, and where there's no public pressure (yet?) to intervene. Don't get me wrong -- I'm not opposed to the idea of med app oversight, someday. There's no doubt that would be good for Americans. I do worry, though, that by moving in to the medical apps realm before most people have ever used them, and before a bad outcome has even been encountered -- or learned from -- is premature. Though the FDA says they don't want to stifle innovation, I can't imagine that, with their current budget, their fees and regulations can be anything other than a significant hurdle for developers.